The NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) Follow-up Study

Not Applicable

Recruiting

• Conditions: congenital heart disease; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12621000904875
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-12
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 868

Inclusion Criteria

* Enrolled in the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC; ACTRN12617000821392) randomised controlled trial
* Consent of parents/guardian for long-term follow-up

Exclusion Criteria

Children are enrolled in the original NITRIC RCT are eligible for this study, therefore the same exclusion criteria as for the NITRIC RCT will apply:
•Signs of persistently elevated pulmonary vascular resistance preoperatively requiring inhaled NO or preoperative intravenous use of drugs involved in the NO pathway such as glyceryl trinitrate, within 48 hours prior to CPB (oral sildenafil treatment alone is not an exclusion);
•Patient is on ECLS immediately prior to surgery;
•Chronic ventilator dependency;
•Concurrent known confirmed bacterial sepsis/septic shock, diagnosed within <48hours prior to surgery and being actively treated with antibiotics at time of surgery (suspected sepsis treated with antibiotics is not an exclusion criteria unless inotropes are required for treatment of septic shock at time of surgery);
•Preoperative acute respiratory distress syndrome requiring high frequency oscillatory ventilation <48 hours of surgery;
•Patient requires high doses of vasoactive drugs prior to surgery with an inotrope score >=15 met within 24 hours prior to surgery: Inotrope requirement will be calculated by means of the Vasoactive-Inotrope Score (VIS) (2): VIS = dopamine dose (mcg/kg/min) + dobutamine dose (mcg/kg/min) + 100 x adrenaline dose (mcg/kg/min) + 100 x noradrenaline dose (mcg/kg/min) + 10 x milrinone dose (mcg/kg/min) + 10,000 x vasopressin dose (U/kg/min);
•Cardiac arrest within one week (seven days) prior to surgery;
•Emergency cardiac surgery which may preclude obtaining informed consent (defined as acutely required life-saving procedure in a patient unlikely to survive the next hours without the surgery); and
•Pre-existing methaemoglobinemia (MetHb>3%).

Study & Design

• Study Type: Observational
• Study Design: Not specified